Ranjith Kumar CHAPALA
Boston,MA
Summary
I acquired a deep understanding of various regulatory activities and submissions from my master's in Regulatory Affairs, and I dream of working for a reputable organization. I am a qualified clinical research associate with 5 years of substantial experience in the pharmaceutical and biotech industry with the goal of steering public safety and contributing to the success of the organization.
Overview
6
6
years of professional experience
Work History
Clinical Research Associate
DECIBEL THERAPEUTICS
Boston, MA
01.2023 - 07.2023
- Conducted pre-study visits specific to the Therapeutic Area of Hearing Loss-Rare Disease in Phase II, discussing protocol, study requirements, and documentation with Investigators and trial staff, ensuring compliance with local regulations and ICH-GCP standards
- Meticulously reviewed ISF binders for inconsistencies and errors, rectifying promptly to maintain high-quality standards
- Collaborated closely with cross-functional teams, addressing document-related queries and ensuring smooth workflow throughout the study
- Tracked study progress by reviewing eCRF, Enrollment numbers regularly and providing updates as needed
- Developed comprehensive knowledge of Good Clinical Practice guidelines and regulations to ensure protocol compliance
- Provided comprehensive support to all phases of clinical trials, adhering to timelines and achieving study goals in line with FDA, EMEA, GCP, and ICH guidelines
- Supported the completeness and timeliness of document submissions to the Trial Master File and Investigator Site File, maintaining accurate trial documentation while assisting in database setup and user testing
- Guided and supported executing protocols for new product developments through crossover from headquarters
- Worked with Quality team on projects CAPA as a part of quality and minimize errors.
Regulatory and Study Start up Specialist
IQVIA
Bangalore, India
12.2020 - 12.2021
- Proficiently and supervised clinical research studies in oncology and Covid 19 across all phases, from Phase I to IV, ensuring adherence to regulatory requirements and project timelines
- Acted as the Single Point of Contact (SPOC) for investigative sites, collaborating with internal stakeholders such as RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership, and GICS, to facilitate smooth project execution
- Ensured compliance with SOPs and quality standards for designated deliverables, contributing to project success and regulatory adherence
- Managed Regulatory, Start-up, and Maintenance activities in accordance with regulations, maintaining accurate documentation and distributing necessary documents to sites and internal team members
- Oversaw site regulatory document preparation and review, negotiated site contracts and budgets, monitored site performance metrics, and collaborated on project planning and timelines, actively striving for efficiency and quality improvement throughout the project lifecycle
- Performs execution of CTAs as well as budget negotiation and capture of metadata
- Review and negotiate the CDAs according to country specific requirements, seeking legal/management review when required various oral Titrators
- Distribute and track protocol amendments and IRB/ethics approvals of the amendments and follows-up with sites on the start-up process
- Participates in reviewing Safety and Regulatory management plans.
TMF Specialist
IQVIA
Bangalore, India
09.2019 - 11.2020
- Maintained overall completeness and quality of the Trial Master File (TMF) (start up to archival)
- Monitored TMF status updates to trial and cross-functional teams as required
- Performs CRO TMF completeness review for metadata checks and targeted missing items according to each CRO's TMF Plan and TMF Index
- Performed cross-functional activities with internal and external departments work with study team to establish TMF plan & strategy.
Clinical Research Associate
ARDENT CLINICAL RESEARCH SERVICES
Pune, India
06.2018 - 08.2019
- Conducted pre-study visits for rheumatology for Phase III trial, ensuring thorough protocol discussions with PI and trial staff to align with protocol requirements, local regulations, ICH-GCP, and Ardent Clinical SOPs, while assessing site facilities and recruitment potential
- Assisted in Investigator selection, prepared IEC/IRB submissions, regulatory notifications, and translated study-related documentation, alongside managing tasks delegated by the Project Manager
- Negotiated investigator budgets, executed site contracts, and reviewed study-specific plans, manuals, logs, forms, and presentations
- Established, updated, tracked, and maintained CTMS and study-specific trial management tools/systems, while conducting initiation visits to train Investigators and trial staff on protocol and data collection methods, ensuring compliance with regulations and SOPs
- Managed study-related trackers generated weekly reports, updated data in EDC systems, performed data management review, processed SAEs, liaised with data management, conducted closeout visits, prepared visit reports, and initiated payment requests for Investigators/Vendors/Institution & Medical Management, collaborating with internal workgroups to evaluate needs, resources, and timelines
- Performed data management review, including in-house CRF review, and alerts project managers and data managers to emerging issues with CRF completion.
Clinical Research Coordinator
ST THERESA HOSPITAL
Hyderabad, India
01.2017 - 05.2018
- Managed the implementation of multiple complex clinical research protocols and adherence to regulatory requirements.
- Submitted comprehensive dossiers to Ethics Committees, facilitating approval processes and facilitate eligibility screening and study recruitment activities.
- Managed sample processing, packing and shipping according to protocol and applicable standards as per ICH-GCP.
- Organized site visits and internal/external auditing activities as assigned.
- Assures synchronization of study visits/medical procedures/ clinical tests with data collection schedules, established time-points.
- Collaborated closely with Principal Investigators, ensuring adherence to regulatory requirements, maintaining meticulous study documentation, and managing investigational products and supplies efficiently to support smooth study operations
- Ensured all safety data is reviewed by PI in a timely manner.
- Manage day to day activities of the study with CRO, sponsor and PI
Education
Master of Science in Regulatory Affairs - Regulatory Affairs
Northeastern University
12.2023
Doctor of Pharmacy -
Malla Reddy University
06.2018
Skills
- GCP- Good Clinical Practice
- HSR- Human Studies Research
- GLP- Good Laboratory Practice
- ASCLS PACE- Transporting Dangerous Goods Training
- Veeva Vault
- CITI- Biomedical Research Investigators
- CITI- Initial Biosafety Training
- ACRP- Ensuring Quality in Fast Enrolling Trails
- MS Office (Word, Excel, PowerPoint)
- Medidata
- EDC- Electronic Data Capture
- Good oral communication skills
References
References available upon request.
Timeline
Clinical Research Associate
DECIBEL THERAPEUTICS
01.2023 - 07.2023
Regulatory and Study Start up Specialist
IQVIA
12.2020 - 12.2021
TMF Specialist
IQVIA
09.2019 - 11.2020
Clinical Research Associate
ARDENT CLINICAL RESEARCH SERVICES
06.2018 - 08.2019
Clinical Research Coordinator
ST THERESA HOSPITAL
01.2017 - 05.2018
Master of Science in Regulatory Affairs - Regulatory Affairs
Northeastern University
Doctor of Pharmacy -
Malla Reddy University
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